RecruitingPhase 2NCT06487039

Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration

A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration


Sponsor

EyebioKorea, Inc.

Enrollment

50 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration. The purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)


Eligibility

Min Age: 50 Years

Inclusion Criteria3

  • Adults aged 50 years or older
  • Subjects with a best corrected visual acuity (BCVA) score between 25 and 73, measured by the Early Treatment of Diabetic Retinopathy Study(ETDRS) chart, at a distance of 4 m during the screening (equivalent to 20/40 to 20/320 in the Snellen chart)
  • Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study

Exclusion Criteria10

  • Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)
  • Subjects who have received ocular or systemic treatment, such as photodynamic therapy (PDT) or laser photocoagulation, or have undergone a surgical operation for nAMD (however, health functional foods, vitamin supplements, etc., are excluded)
  • Subjects whose study eye has been treated with anti-vascular endothelial growth factor (anti-VEGF) drugs (e.g. ranibizumab, bevacizumab, aflibercept, etc.) or a combination therapy for the treatment of nAMD prior to screening
  • Subjects who have received intravitreal treatment using steroids
  • Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area
  • Subjects with vitreous hemorrhage in the study eye
  • Subjects who have undergone vitrectomy
  • Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment
  • Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
  • Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)

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Interventions

DRUGEB-203

Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.


Locations(5)

Busan Paik Hospital, Inje University

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Kim's Eye Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06487039


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